ID

34828

Beschrijving

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the Serious Adverse Events (SAE). It has to be filled in if a SAE occurs during study.

Trefwoorden

Versies (2)
  1. 29-01-19 29-01-19 -
  2. 30-01-19 30-01-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

30 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Engels

Serious Adverse Events (SAE)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschrijving

Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Beschrijving

Randomisation Number

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Serious Adverse Events, Section 1
Beschrijving

Serious Adverse Events, Section 1

Alias
UMLS CUI-1
C1519255
SAE Diagnosis
Beschrijving

Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE however if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page.

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Start date of SAE
Beschrijving

day month year. Record the start date of the first occurrence of the SAE.

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Start time of SAE
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Outcome of SAE
Beschrijving

All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was 'Recovered/Resolved' or 'Recovered/Resolved with sequelae'. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as 'Not recovered/Not resolved' or 'Recovering/Resolving'. Also enter 'Not recovered/Not resolved' if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
If fatal, was a post-mortem/autopsy performed?
Beschrijving

If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C1705586
UMLS CUI [2,1]
C0004398
UMLS CUI [2,2]
C1518965
End date of SAE, Date of death
Beschrijving

day month year. Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/Resolved with sequelae, enter the date the subJect's medical condition resolved or stabilised. Leave blank if the SAE is 'Not recovered/Not resolved' or 'Recovering/Resolving'.

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C1148348
End time of SAE
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Maximum Intensity of SAE
Beschrijving

Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with everyday activities Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

Datatype

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with investigational Product(s) as a Result of the SAE
Beschrijving

lnvestigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = lnvestigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).

Datatype

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE?
Beschrijving

Indicate 'Yes' if the event(s) were directly responsible for the subject's withdrawal as indicated on the Study Conclusion page, otherwise indicate 'No'. If you tick yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschrijving

It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. 'A reasonable possibility' is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support 'a reasonable possibility' include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C1519255
Seriousness, Section 2
Beschrijving

Seriousness, Section 2

Alias
UMLS CUI-1
C1710056
Results in death
Beschrijving

Results in death

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1519255
Is life-threatening
Beschrijving

Note: The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe.

Datatype

boolean

Alias
UMLS CUI [1]
C1517874
Requires hospitalization or prolongation of existing hospitalization
Beschrijving

Note: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is 'serious'. When in doubt as to whether 'hospitalisation' occurred or was necessary, the AE should be considered 'serious'. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0745041
UMLS CUI [2,2]
C1519255
Results in disability/incapacity
Beschrijving

Note: The term disability means a substantial disruption of a person's ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g. , sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Congenital anomaly/birth defect
Beschrijving

Congenital anomaly/birth defect

Datatype

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other seriousness
Beschrijving

Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1710056
If other, please specify
Beschrijving

Other seriousness, specification

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1710056
Demography Data, Section 3
Beschrijving

Demography Data, Section 3

Alias
UMLS CUI-1
C0011298
Date of birth
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
Body Weight
Beschrijving

Body Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Administration of reported event(s) recur after further investigational product(s), Section 4
Beschrijving

Administration of reported event(s) recur after further investigational product(s), Section 4

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0034897
UMLS CUI-3
C1517331
UMLS CUI-4
C0304229
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
Beschrijving

If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C1517331
UMLS CUI [1,4]
C0304229
Possible Causes of SAE other than lnvestigational Product(s), Section 5
Beschrijving

Possible Causes of SAE other than lnvestigational Product(s), Section 5

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C1519255
UMLS CUI-3
C0085978
Disease under study
Beschrijving

Disease under study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Medical condition(s)
Beschrijving

record in Section 6

Datatype

boolean

Alias
UMLS CUI [1]
C0012634
Lack of efficacy
Beschrijving

Lack of efficacy

Datatype

boolean

Alias
UMLS CUI [1]
C0235828
Withdrawal of investigational product(s)
Beschrijving

Withdrawal of investigational product(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant medication
Beschrijving

Record in Section 8

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Activity related to study participation (e.g., procedures)
Beschrijving

Activity related to study participation (e.g., procedures)

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0199171
Other causation of SAE
Beschrijving

Other causation of SAE

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0085978
If other causation, please specify
Beschrijving

Other, specification

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0085978
Relevant medical conditions, Section 6
Beschrijving

Relevant medical conditions, Section 6

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0262926
Specific Condition Name
Beschrijving

Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE

Datatype

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Date of onset
Beschrijving

day month year.

Datatype

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
Condition present at time of the SAE?
Beschrijving

Condition present at time of the SAE

Datatype

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If no condition present at time of the SAE, please specify date of last occurence
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0012634
Other Relevant Risk Factors, Section 7
Beschrijving

Other Relevant Risk Factors, Section 7

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C1519255
Other relevant risk factors
Beschrijving

provide any family or social history (e.g. , smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE

Datatype

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
Relevant concomitant medications, Section 8
Beschrijving

Relevant concomitant medications, Section 8

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1519255
Drug name, medication
Beschrijving

(Trade name preferred)

Datatype

text

Alias
UMLS CUI [1]
C0013227
Drug Dose, medication
Beschrijving

Drug Dose, medication

Datatype

integer

Alias
UMLS CUI [1,1]
C0869039
UMLS CUI [1,2]
C0013227
Dose unit
Beschrijving

Dose unit

Datatype

text

Alias
UMLS CUI [1]
C2826646
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C0013227
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Taken prior to study
Beschrijving

Taken prior to study

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Start date, SAE
Beschrijving

day month year.

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Stop date, SAE
Beschrijving

day month year.

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Ongoing medication?
Beschrijving

Ongoing medication

Datatype

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0013227
Reason for medication
Beschrijving

Reason for medication

Datatype

text

Alias
UMLS CUI [1]
C2826696
Details of investigational product(s), Section 9
Beschrijving

Details of investigational product(s), Section 9

Alias
UMLS CUI-1
C0304229
Treatment period
Beschrijving

Treatment period

Datatype

integer

Alias
UMLS CUI [1]
C2347804
Start date, investigational product
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Start time, investigational product
Beschrijving

00:00-23:59

Datatype

date

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0304229
Was treatment blind broken at investigational site?
Beschrijving

Treatment blind broken at investigational site

Datatype

text

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
Details of relevant Assessment, Section 10
Beschrijving

Details of relevant Assessment, Section 10

Alias
UMLS CUI-1
C1261322
UMLS CUI-2
C1519255
Relevant Assessments
Beschrijving

Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range.

Datatype

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
Narrative Remarks, Section 11
Beschrijving

Narrative Remarks, Section 11

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1519255
Narrative Remarks
Beschrijving

Provide a brief narrative description of the SAE and details of treatment given.

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigator's signature
Beschrijving

Confirming that the data on the SAE pages are accurate and complete.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Beschrijving

Investigator's name

Datatype

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Serious Adverse Events (SAE)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Serious Adverse Events, Section 1
C1519255 (UMLS CUI-1)
SAE Diagnosis
Item
SAE Diagnosis
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Start date of SAE
Item
Start date of SAE
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Start time of SAE
Item
Start time of SAE
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome of SAE
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome of SAE
Code List
Outcome of SAE
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
Item
If fatal, was a post-mortem/autopsy performed?
text
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,3])
C0004398 (UMLS CUI [2,1])
C1518965 (UMLS CUI [2,2])
Outcome of SAE
Code List
If fatal, was a post-mortem/autopsy performed?
CL Item
Yes (Y)
CL Item
No (N)
End date of SAE, Date of death
Item
End date of SAE, Date of death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
End time of SAE
Item
End time of SAE
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity of SAE
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity of SAE
Code List
Maximum Intensity of SAE
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not aplicable (X)
Item
Action Taken with investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action taken with investigational Product(s)
Code List
Action Taken with investigational Product(s) as a Result of the SAE
CL Item
lnvestigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this SAE?
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawing as result of SAE
Code List
Did the subject withdraw from study as a result of this SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C0304229 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Investigational product causing SAE
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Seriousness, Section 2
C1710056 (UMLS CUI-1)
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
Hospitalization/ prolongation of existing hospitalization
Item
Requires hospitalization or prolongation of existing hospitalization
boolean
C0019993 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other seriousness
Item
Other seriousness
boolean
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Other seriousness, specification
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Item Group
Demography Data, Section 3
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Item Group
Administration of reported event(s) recur after further investigational product(s), Section 4
C0877248 (UMLS CUI-1)
C0034897 (UMLS CUI-2)
C1517331 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
Item
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
text
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
undefined item
Code List
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Possible Causes of SAE other than lnvestigational Product(s), Section 5
C0205394 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0085978 (UMLS CUI-3)
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Medical condition(s)
Item
Medical condition(s)
boolean
C0012634 (UMLS CUI [1])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1])
Activity related to study participation (e.g., procedures)
Item
Activity related to study participation (e.g., procedures)
boolean
C2348568 (UMLS CUI [1,1])
C0199171 (UMLS CUI [1,2])
Other causation of SAE
Item
Other causation of SAE
boolean
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Other, specification
Item
If other causation, please specify
text
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Item Group
Relevant medical conditions, Section 6
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item
Condition present at time of the SAE?
text
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Condition present at time of the SAE
Code List
Condition present at time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
Date of last occurence
Item
If no condition present at time of the SAE, please specify date of last occurence
date
C2745955 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
Item Group
Other Relevant Risk Factors, Section 7
C0035648 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Other relevant risk factors
Item
Other relevant risk factors
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Relevant concomitant medications, Section 8
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Drug name, medication
Item
Drug name, medication
text
C0013227 (UMLS CUI [1])
Drug Dose, medication
Item
Drug Dose, medication
integer
C0869039 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Dose unit
text
C2826646 (UMLS CUI [1])
Dose unit
Code List
Dose unit
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
As required (PRN)
CL Item
1 X Daily (OD/QD)
CL Item
2 X Daily (BID)
CL Item
3 x Daily (TIO)
CL Item
4 x Daily (QID)
CL Item
Single dose (ONCE)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Item
Taken prior to study
text
C2347852 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Taken prior to study
Code List
Taken prior to study
CL Item
Yes (Y)
CL Item
No (N)
Start date, SAE
Item
Start date, SAE
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Stop date, SAE
Item
Stop date, SAE
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Ongoing medication?
text
C0549178 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Ongoing
Code List
Ongoing medication?
CL Item
Yes (Y)
CL Item
No (N)
Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Item Group
Details of investigational product(s), Section 9
C0304229 (UMLS CUI-1)
Item
Treatment period
integer
C2347804 (UMLS CUI [1])
Recurrence of Adverse event after further investigational product
Code List
Treatment period
CL Item
Treatment period 1 (1)
CL Item
Treatment period 2 (2)
CL Item
Treatment period 3 (3)
CL Item
Treatment period 4 (4)
Start date, investigational product
Item
Start date, investigational product
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Start time, investigational product
Item
Start time, investigational product
date
C1301880 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational site?
text
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Treatment blind broken at investigational site
Code List
Was treatment blind broken at investigational site?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Item Group
Details of relevant Assessment, Section 10
C1261322 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Relevant Assessments
Item
Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Narrative Remarks, Section 11
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Narrative Remarks
Item
Narrative Remarks
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
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